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临床试验/NCT07825779
NCT07825779已完成不适用

The Effect of Cold Application on Nausea and Vomiting After Bariatric Surgery

Sakarya University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Visual Analogue Scale (VAS)

研究概览

简要总结

Obesity is a chronic disease resulting from an excess of body fat mass relative to lean body mass, characterized by a deterioration in the individual's quality of life and health (Kayar and Utku, 2013; Usta and Çavdar, 2013; Tam and Çakır, 2012; Tuncalı et al., 2018). Bariatric surgery is becoming increasingly common worldwide. Nausea and vomiting are among the most frequently observed complications in these patients. This study will be conducted to assess patients for the risk of nausea and vomiting and to examine the effects of a cold application nursing intervention. The lack of sufficient literature measuring nausea and vomiting in patients following bariatric surgery prompted us to undertake this study.

详细描述

The analysis of the patients' pre- and post-operative scale scores in this study is expected to reveal an improvement in quality of life, consistent with the findings of similar studies. It is anticipated that the patients' quality of life will increase as they achieve their desired weight and body image, gain mobility, and become more independent in their daily lives. Quality of life is defined as the level of satisfaction shaped by an individual's abilities and lifestyle. Obesity frequently impacts quality of life negatively by affecting the individual psychosocially-particularly through dissatisfaction with their physical appearance.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals over the age of 18
  • Patients accessible prior to surgery
  • Those scheduled to receive general anesthesia only
  • Conscious individuals
  • Individuals without cognitive or psychiatric disorders

排除标准

  • Individuals under the age of 18
  • Those who experienced serious complications during or after surgery
  • Individuals with hearing, visual, speech, or cognitive dysfunction
  • Those without neurological problems
  • Patients who do not consent to the procedure

研究组 & 干预措施

Experimental group subjected to ice application

Experimental

Upon the individual's arrival at the unit, the status of nausea (including severity) and vomiting was assessed, and physiological parameters were measured. A cold compress wrapped in gauze was applied to the patient's upper neck area and left in place for five minutes. Following the procedure, the status of nausea (including severity), vomiting, and physiological parameters was re-evaluated. The use of antiemetic and opioid medications was also recorded.

干预措施: ICE (Other)

CONTROL

No Intervention

When the individual arrived at the unit, their nausea status (including severity) and vomiting status were assessed, and physiological parameters were measured prior to the intervention. No cold application was performed. Following the procedure, nausea status (including severity), vomiting status, and physiological parameters were reassessed. The use of antiemetic and opioid medications was also recorded.

结局指标

主要结局

Visual Analogue Scale (VAS)

时间窗: 15 months

The VAS is a scale ranging from 0 ("no nausea") to 10 ("very severe nausea"), with numerical values assigned at one-centimeter intervals. The following were rated: nausea severity, peak nausea severity, nausea severity during activity, nausea severity at rest, retching/vomiting severity, and peak retching/vomiting severity.

次要结局

  • Apfel Nausea and Vomiting Risk Score(15 MONTHS)

研究者

发起方
Sakarya University
申办方类型
Other
责任方
Principal Investigator
主要研究者

özlem doğu

ASSOCIATE PROFFESSOR

Sakarya University

研究点 (1)

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